InfluenzaPhase 3IVVNCT01551810
The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)
A Phase 3 study testing Influenza Virus Vaccine and Influenza Virus Vaccine(contains Preservative) in people with Influenza, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative . Read more about this study
- Who is it for?
- Ages 36 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Virus Vaccine and Influenza Virus Vaccine(contains Preservative)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Aug 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males and females, age above 36 months ;
- Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
- Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
- Infants no vaccinated with influenza or other preventive biologicals in recent 7 days;
- Axillary temperature ≤37℃.
Who cannot join
- Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy;
- Low platelet or bleeding disorder do not allow vaccination into the muscle;
- Have damaged or lower immunological function;
- Received blood, plasma or immunoglobulin treatment since birth;
- Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
- Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
Trial locations and contacts
1 site in 1 country.
China1 site
Dingxing Center for Disease Prevention and Control
Shijiazhuang, Hebei
About this study
Official title: The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)
The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative .
Read the detailed description
Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative. HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.
Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.
This is a randomized, blind phase 3 clinical trial. Total 1200 adults (above ages 36 months ) were selected, randomized to two groups [Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600], adults in each group will be vaccinated with one dose of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively.
- Conditions
- Influenza
- Being tested
- Influenza Virus Vaccine, Influenza Virus Vaccine(contains Preservative)
- Keywords
- Influenza Virus Vaccine (Split Virion, Inactivated), Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza Virus VaccineBiological
Influenza Virus Vaccine 0.5ml intramuscular injections
Influenza Virus Vaccine(contains Preservative)Biological
Also called Vaxigrip
Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections
| Study group | Role | What they receive |
|---|---|---|
| Influenza Virus Vaccine | Experimental | Influenza Virus Vaccine（no Preservative ) 0.5ml intramuscular injections Receives: Biological: Influenza Virus Vaccine; Biological: Influenza Virus Vaccine(contains Preservative) |
| Influenza Virus Vaccine(Preservative) | Experimental | Influenza Virus Vaccine（add Preservative ) 0.5ml intramuscular injections Receives: Biological: Influenza Virus Vaccine; Biological: Influenza Virus Vaccine(contains Preservative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Provincial Center for Diseases Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Guoyang Liao, Ph. D, Principal investigator, Institute of Medical Biology, Chinese Academy of Medical SciencesYuliang Zhao, MD, Principal investigator, Hubei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551810
- Sponsor's protocol ID
- IMBCAMS-04
- Other IDs
- 2011L01488
- Acronym
- IVV
- Status last verified
- Oct 2023
- First submitted
- 8 Mar 2012
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jing-Xia G, Yu-Liang Z, Jin-Feng L, Shu-Zhen L, Guo-Yang L, Qi L. Safety and effectiveness assessment of 2011-2012 seasonal influenza vaccine produced in China: a randomized trial. Postgrad Med. 2017 Nov;129(8):907-914. doi: 10.1080/00325481.2017.1369133. Epub 2017 Sep 5.
PubMed 28825515
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)
- ClinicalTrials.gov ID
- NCT01551810
- Acronym / sponsor ID
- IVV / IMBCAMS-04
- Conditions
- Influenza
- Keywords
- Influenza Virus Vaccine (Split Virion, Inactivated), Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Hebei Provincial Center for Diseases Control and Prevention
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative .
Detailed description
Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative. HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.
Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.
This is a randomized, blind phase 3 clinical trial. Total 1200 adults (above ages 36 months ) were selected, randomized to two groups [Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600], adults in each group will be vaccinated with one dose of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Virus Vaccine | Experimental | Biological: Influenza Virus Vaccine, Biological: Influenza Virus Vaccine(contains Preservative)Influenza Virus Vaccine（no Preservative ) 0.5ml intramuscular injections |
| Influenza Virus Vaccine(Preservative) | Experimental | Biological: Influenza Virus Vaccine, Biological: Influenza Virus Vaccine(contains Preservative)Influenza Virus Vaccine（add Preservative ) 0.5ml intramuscular injections |
Who may qualify
- Ages
- 36 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females, age above 36 months ;
- Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
- Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
- Infants no vaccinated with influenza or other preventive biologicals in recent 7 days;
- Axillary temperature ≤37℃.
Key exclusion criteria (6 listed)
- Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy;
- Low platelet or bleeding disorder do not allow vaccination into the muscle;
- Have damaged or lower immunological function;
- Received blood, plasma or immunoglobulin treatment since birth;
- Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza Virus VaccineInfluenza Virus Vaccine 0.5ml intramuscular injections | Biological | Influenza Virus Vaccine, Influenza Virus Vaccine(Preservative) |
| Influenza Virus Vaccine(contains Preservative)Also: VaxigripInfluenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections | Biological | Influenza Virus Vaccine, Influenza Virus Vaccine(Preservative) |
Primary outcome
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 28825515Jing-Xia G, Yu-Liang Z, Jin-Feng L, Shu-Zhen L, Guo-Yang L, Qi L. Safety and effectiveness assessment of 2011-2012 seasonal influenza vaccine produced in China: a randomized trial. Postgrad Med. 2017 Nov;129(8):907-914. doi: 10.1080/00325481.2017.1369133. Epub 2017 Sep 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoyang Liao, Ph. D principal investigator
Institute of Medical Biology, Chinese Academy of Medical Sciences
Yuliang Zhao, MD principal investigator
Hubei Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Influenza Virus Vaccine and Influenza Virus Vaccine(contains Preservative) in people with Influenza, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.